Multi-component contact lens having posterior and anterior features

ABSTRACT

An ophthalmic device having posterior and anterior features are disclosed herein. An example ophthalmic device may include an enclosure having an insert disposed therein. The enclosure may include a cornea contact disposed on a posterior side and arranged to rest on a user&#39;s cornea outside of a central cornea area when the ophthalmic device is worn by a user. The enclosure further includes a channel formed in the posterior side, where the channel extends through the cornea contact from at least radially outside of the insert to an inner edge of the cornea contact.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.15/274,255, filed on Sep. 23, 2016, the contents of which areincorporated herein by reference.

TECHNICAL FIELD

This disclosure relates generally to an ophthalmic device, and inparticular, relates to a wearable contact lens.

BACKGROUND INFORMATION

On-eye wearable ophthalmic devices, such as contact lenses, may beformed in a variety of structures, such as soft contact lenses, hardcontact lenses, and hybrid contact lenses, to name a few. A hybridcontact lens is a combination of soft and hard contact lenstechnologies. The various structures have their own advantages anddisadvantages. For example, soft lenses may be easier to fit and be morecomfortable to wear than hard lenses, but they may not provide qualityoptics as do the hard lenses. Conversely, hard lenses may be difficultto fit, which typically require iterative fittings with differentcurvatures to settle on a comfortable fit. While hybrid lenses mayprovide some combination of the benefits of each, they may typicallystill require multiple fittings to obtain the desired comfortable fit.

While various designs have been tried, the disadvantages of the variousdesigns persist. These disadvantages, if not addressed, may increase thecomplexity of design, manufacturing and stock maintenance of futurelenses. As such, it may be desirable to reduce or eliminate suchdisadvantages.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting and non-exhaustive embodiments of the invention aredescribed with reference to the following figures, wherein likereference numerals refer to like parts throughout the various viewsunless otherwise specified. Not all instances of an element arenecessarily labeled so as not to clutter the drawings where appropriate.The drawings are not necessarily to scale, emphasis instead being placedupon illustrating the principles being described.

FIG. 1 is an illustrative plan view of an ophthalmic system includingposterior and anterior features in accordance with an embodiment of thedisclosure.

FIG. 2 is an illustrative perspective view of an ophthalmic deviceincluding posterior and anterior features in accordance with anembodiment of the disclosure.

FIG. 3 is an illustrative cross-sectional view of a central area of anophthalmic device including posterior and anterior features inaccordance with an embodiment of the disclosure.

FIG. 4 is an illustrative plan view of an ophthalmic device includingposterior and anterior features in accordance with an embodiment of thedisclosure.

FIG. 5 is a functional block diagram of an ophthalmic device includingposterior and anterior features in accordance with an embodiment of thedisclosure.

DETAILED DESCRIPTION

Embodiments of an ophthalmic device having tear fluid exchange features,and alignment features are described herein. For example, channelsformed on a posterior side of the ophthalmic device may provide for tearfluid exchange between the cornea under the ophthalmic device and theeye external to the ophthalmic device. Additionally, features formed onan anterior side of the ophthalmic device may provide for alignment ofan insert of the ophthalmic device with an enclosure of the ophthalmicdevice. In the following description numerous specific details are setforth to provide a thorough understanding of the embodiments. Oneskilled in the relevant art will recognize, however, that the techniquesdescribed herein can be practiced without one or more of the specificdetails, or with other methods, components, materials, etc. In otherinstances, well-known structures, materials, or operations are not shownor described in detail to avoid obscuring certain aspects.

Reference throughout this specification to “one embodiment” or “anembodiment” means that a particular feature, structure, orcharacteristic described in connection with the embodiment is includedin at least one embodiment of the present invention. Thus, theappearances of the phrases “in one embodiment” or “in an embodiment” invarious places throughout this specification are not necessarily allreferring to the same embodiment. Furthermore, the particular features,structures, or characteristics may be combined in any suitable manner inone or more embodiments.

As discussed above, the various conventional contact lens structures allhave their own advantages and disadvantages. These advantages anddisadvantages may also affect smart contact lenses. The advent ofelectronic lenses, e.g., smart contact lenses, may include electronicsand sensors that provide various functionality. Such electronic lenses,however, may be similar in structure to hybrid lenses due to theelectronics and sensors being desirably enclosed in a biocompatiblematerial. Smart contact lenses may include dynamic optics and associatedcontrol electronics, which may provide accommodation through the controlof the dynamic optic. Smart contact lenses may be similar in structureto hybrid lenses in that they include an insert disposed within anenclosure, where the insert may house the dynamic optics and associatedcontrol. Hybrid lens-type structures, however, may include variousproblems that may affect their wearability and fitting. These featuresmay pose difficulties in fabrication and adoption of smart contactlenses by the lens-wearing public.

For example, hybrid lenses may require iterative fittings to ensureproper fit on a user's eye. The difficulty in fitting may be due to theinsert, which may be rigid, and how the insert affects the comfort ofthe lens. Additionally, suction of the hybrid lens to the user's eye maycause difficulty in removal by the user, which may cause incidents ofrequiring their removal by an eye care provider. Exchange of tear fluidfrom on and around the central cornea with fresh tear fluid may also bedifficult if the hybrid lens does not include passageways for suchexchange. In some instances, lack of fresh tear fluid and oxygen maylead to damage of the cornea. The problem with suction and the lack oftear fluid exchange may be due to the same hybrid lens features, and mayboth be present.

Moreover, due to the iterative fitting process, each pair of hybridlenses are essentially personalized, which requires fabrication ofnumerous hybrid lenses. The number of hybrid lenses, which may equal thenumber of wearers, may complicate manufacturing, assembly, and inventorymanagement.

As such, it may be desirable to have a small number of hybrid lensdesigns per optical prescription. Such hybrid lenses may easemanufacturing allowing for high volume processing instead ofindividualized fabrication. Additionally, the one or two hybrid lensesmay include features that allow for the exchange of tear fluid and easeof lens removal, e.g., that also reduce or eliminate the incident ofsuction. Further, the hybrid lens may include alignment features thatmay simplify assembly and that provide alignment fiducials for obtainingcentricity between an insert and an enclosure.

For example, the present disclosure may provide for an enclosure thatmay encapsulate a pre-formed semi-rigid to rigid insert such as a rigidgas permeable contact lens or an electronic insert, rigid or soft. Theenclosure may include geometries and/or features that may provide avariety of benefits. For example, the enclosure's features may provide ameans for aiding fabrication during over molding of contact lensenclosure material by incorporating internal standoff features.Additionally, enclosure features may provide anterior channel/ventcontours that may prevent or reduce the incidence of mechanical suctionof the lens to the eye during wear, thereby facilitating lens removal.The enclosure may include posterior contours that allow the contact lensto fit onto a wide population of contact lens wearers. The enclosurefeatures may further provide fiducials useful as assembly aids and/orpost-fabrication inspection. Lastly, the enclosure may includegeometries and features that may provide enhanced tear fluid exchange inand around the central cornea region.

FIG. 1 is an illustrative plan view of an ophthalmic device 100including posterior and anterior features in accordance with anembodiment of the present disclosure. The ophthalmic device 100 may bean on-eye wearable device or an implantable device. The ophthalmicdevice 100, for example, may be placed over a user's cornea to providevarious optical and/or benefits, such as vision correction,accommodation, medical monitoring, and the like. Alternatively, theophthalmic device 100 may be an intraocular device amenable toimplantation into a user's eye. The ophthalmic device 100 may include aninsert 102 disposed in an enclosure 104. The enclosure 104 may havevarious features formed on a posterior and/or an anterior side toenhance wearability and/or assembly. In some embodiments, the posteriorside and/or anterior side features may have discrete rotational symmetryof the nth order, where n may be an odd number greater than or equal tothree.

The insert 102 may provide optical properties to the ophthalmic device100, such as static and/or dynamic optical power, and may be positionedover a central area of a user's cornea when the ophthalmic device isworn on the eye. The insert 100 may have the form of a semi-sphericalshell having a diameter, a radius of curvature of a posterior side and aradius of curvature of an anterior side. The posterior side may be aneye-facing side, whereas the anterior side may be an external facingside. Stated another way, the posterior side may be concave and theanterior side may be convex. In some embodiments, the insert 102 may bearound 10 mm in diameter, and have a radius of curvature on theposterior side of around 8 mm. The insert 102 may have variousthicknesses, and in some embodiments may change in thickness in a radialdirection from a central axis to a perimeter. The thickness of theinsert, however, may be a non-limiting aspect of the present disclosure.

The insert 102 may be rigid or soft. In some embodiments, the insert 102may be a pre-formed rigid insert that is formed from a rigid, gaspermeable polymer. In some embodiments, the insert 102 may be soft, andformed from a biocompatible elastomer, such as a silicone elastomer, forexample. In some embodiments, the insert 102 may include control logicand a dynamic optic controlled by the control logic. Additionally, insome embodiments, the insert 102 may be formed from multiple components.In general, the insert 102 may be enclosed in the enclosure 104 and,when worn by a user, be centrally located over the user's cornea toprovide one or more optical properties to the user.

The enclosure 104 may envelope the insert 102 and may include variousfeatures, such as contours, ridges, fenestrations, bumps, etc., thatprovide various assembly and wearability aspects to the ophthalmicdevice 100. The enclosure 104 may be formed from a flexible,biocompatible polymer. For example, the enclosure 104 may be formed froma hydrogel, silicone hydrogel, or silicone elastomer. The enclosure 104may also be referred to as an over mold or an encasement. Similar to theinsert 102, the enclosure 104 may have the form of a semi-sphericalshell having a diameter, a posterior side, e.g., eye-ward facing side,and an anterior side, e.g., external facing side. The posterior side maybe concave and correspond to the posterior side of the insert 102, whilethe anterior side may be convex and correspond to the anterior side ofthe insert 102. The posterior side may be characterized by havingmultiple radii of curvatures, which may be different in different areasof the ophthalmic device 100. For example, a radius of curvature of theenclosure 104 in a center area 106, which may include the diameter ofthe insert 102, may be different than a radius of curvature of theenclosure 104 in a skirt area 108, which may be radially outside of theinsert 102. The center area 106 may also be referred to herein as theoptical area 106. Desired radii of curvature for the center area 106 andthe skirt 108 may allow the ophthalmic device 100 to fit a majority ofthe eye population. The anterior side may have different radii ofcurvature, or it may have a single radii of curvature. The radii ofcurvature of the anterior side may be such as to correct for one or moreof myopia, hyperopia, presbyopia, and/or astigmatism of the wearer, forexample. Further, the diameter of the enclosure 104 may be greater thanthe diameter of the insert 102. For example, the diameter of theenclosure 104 may range from 13 to 16 mm.

The enclosure 104 may include a cornea contact 110 formed therein anddisposed at least under a portion of the perimeter of the insert 102 onthe posterior side of the enclosure 104. The cornea contact 110 may be adiscontinuous toroidal-shaped ring that provides a cornea contact areato the ophthalmic device 100. The cornea contact 110 may contact theuser's eye outside of the central cornea to position the ophthalmicdevice 100 over an optic area of the eye. An amount of area of thecornea contact 110 may affect the wearability, e.g., comfort, of theophthalmic device 100, with more area improving comfort. Whileincreasing the area of the cornea contact 110 may improve wearability,the amount of area available may be limited, at least in part, by thecenter area 106.

The cornea contact 110 may be formed from a raised area on the posteriorside of the ophthalmic device 100. For example, the cornea contact 100may be formed in or on a posterior side of the enclosure 104. Dependingon the height of the cornea contract 110, an amount of clearance betweena posterior side of the enclosure 104 and the central cornea of theuser's eye may be obtained. The clearance may form a chamber between thecentral cornea and the posterior side of the ophthalmic device 100 whichmay be, at least partially, encircled by, e.g., enclosed by or at leastpartially enclosed by, the cornea contact 110. The chamber, which mayalso be referred to herein as a tear fluid chamber, may provide a volumefor tear fluid to accumulate over the central cornea.

The enclosure 104 may further include one or more channels 112. Thechannels 112 may be formed in or on the posterior side of the enclosure104 and may extend through the cornea contact 110 in one or more areas.In some embodiments, the channels 112 may form the discontinuousportions of the cornea contact 110. Each of the channels 112 may extendfrom at least a radius outside of the insert 102 to an internal edge ofthe cornea contact 110, which may be close to the center area 106. Insome embodiments, the channels 112 may extend to at least an outsideedge of the central cornea of the user's eye. In some embodiments, oneor more of the channels 112 may extend radially outward and terminate atan edge of the enclosure 104. While there are three channels 112 shownin FIG. 1, the number of channels and their symmetry is a non-limitingaspect. In general, it may be desirable to include an odd number ofchannels 112 so to ensure an open channel in case of symmetric physicalcharacteristics of the eye close off channels that may align with suchphysical characteristics. For example, including an odd number ofchannels 112 may prevent the ophthalmic device 100 from aligning withany corneal astigmatism present in the wearer.

The enclosure 104 may additionally include one or more fenestrations114. Each of the fenestrations 114, which may be holes or openingsthrough the enclosure 104, may be located at a radius outside of theinsert 102. The fenestrations 114 may extend from the anterior side ofthe enclosure 104 to intersect with a respective one of the channels 112on the posterior side of the enclosure 104. The fenestrations 114 may befrom 100 to 1000 microns in diameter, for example. In some embodiments,the fenestrations 114 may be 400 to 500 microns in diameter.

A combination of the channels 112 and the fenestrations 114 may providea pathway or conduit for the exchange of tear fluid between the tearfluid chamber and an area external to the ophthalmic device 100. Forexample, tear fluid may propagate through one or more of thefenestrations 114 and their respective channels 112 to reach the tearfluid chamber, which may provide fresh tear fluid and oxygen to maintainocular health. Conversely, old tear fluid may escape the tear fluidchamber through the channels 112 and fenestrations 114 whiletransporting mucus and debris away from the central cornea area.

The enclosure 104 may further include one or more offset features 116.Each of the offset features 116 may be formed radially internal of thediameter of the insert 102. The one or more offset features 116, whichmay be non-rotationally symmetric, may be formed in the enclosure 104 toprovide clearance between the insert 102 and the enclosure 104. Forexample, the offset features 116 may provide around 100 microns ofclearance between the insert 102 and the enclosure 104. In someembodiments, the one or more offset features 116 may be formed in or onthe anterior portion of the enclosure 104, which may provide clearancebetween an anterior side of the insert 102 and an internal surface ofthe anterior portion of the enclosure 104. Alternatively oradditionally, the one or more offset features 116 may be formed in theposterior portion of the enclosure 104, and provide clearance between aninternal surface of the posterior portion of the enclosure 104 and theposterior side of the insert 102. The one or more offset features 116may also be alignment features that provide alignment in a directionnormal to the ophthalmic device 100, e.g., in the optical axisdirection. In some embodiments, the one or more offset features 116 maybe bumps formed in the enclosure 104.

Further, the enclosure 104 includes one or more alignment features 118.The one or more alignment features 118 may be formed radially outside ofthe diameter of the insert 102. The one or more alignment features 118may be formed in the enclosure 104 to provide alignment fiducials to aidin assembly of the ophthalmic device 100. For example, the one or morealignment features 118 may provide radial alignment of the insert 102 tothe enclosure 104 so to obtain centration of the insert 102. In someembodiments, the one or more alignment features 118 may be formed in oron the anterior portion of the enclosure 104. Alternatively oradditionally, the one or more offset features 116 may be formed in theposterior portion of the enclosure 104. In some embodiments, the one ormore offset features 116 may be bumps formed in the enclosure 104.

While FIG. 1 shows three offset and alignment features 116 and 118,respectively, the number of offset and alignment features is anon-limiting aspect of the present disclosure. In general, any numberand/or arrangement of offset and alignment features that providenon-rotational symmetry me included in the ophthalmic device 100.Additionally, any shape other than bumps is contemplated by the presentdisclosure, and the bumps example should not be considered limiting.

The skirt 108 may be an area or portion of the enclosure 104 thatconforms to a user's eye outside of the cornea. The skirt 108 may anchorthe ophthalmic device 100 in position, while allowing for movement andremoval of the ophthalmic device 100. For example, the skirt 108 may beflexible so that a user may be able to pinch it to remove the ophthalmicdevice 100 from their eye. Additionally, the skirt 108 may provide agradual decrease in the thickness of the ophthalmic device 100 so to bemore comfortable to the eye and to blinking of the eye. In someembodiments, the radius of curvature of the enclosure 104 in the skirt108 area may be less than the radius of curvature of the enclosure 104in the optic area 106.

FIG. 2 is an illustrative cross-sectional view of an ophthalmic device200 including posterior and anterior features in accordance with thepresent disclosure. The ophthalmic device 200 may be an example of theophthalmic device 100. The ophthalmic device 200 may be an on-eyewearable contact ophthalmic device, which may at least provide opticalbenefits to a wearer.

The illustrated embodiment of the ophthalmic device 200 includes aninsert 202 disposed in an enclosure 204. The enclosure 204 may include acornea contact 210, a plurality of channels 212, a plurality offenestrations 214, and a plurality of offset features 216 (only one ofwhich is shown). The various features may be similar to like features ofthe ophthalmic device 100. The ophthalmic device 200 may have a concaveside (facing down in FIG. 2), and a convex side (facing up in FIG. 2).The concave side may also be referred to as the posterior side, whereasthe convex side may also be referred to as the anterior side. Theophthalmic device 200 may be worn on a user's eye, for example, with theconcave side fitting onto the eye.

The plurality of offset features 216 may be formed on the convex side ofthe ophthalmic device 200, and may provide clearance between the insert202 and an internal surface of the enclosure 204. The plurality ofoffset features 216, which may be bumps formed in/on the anterior sideof the enclosure 204, may be formed inside the diameter of the insert202. Additionally, the plurality of offsets 216 may provide alignmentfeatures in the direction of the optical axis of the ophthalmic device200. While not shown in FIG. 2, the ophthalmic device 200 may further,at least in some embodiments, include a plurality of alignment featuresformed in the enclosure 204 and formed radially outside of the insert202, which may be similar to the one or more alignment features 118.

The cornea contact 210 may provide a broken, or discontinuous, ring ofcontact area intended to contact a perimeter of a user's cornea. Whilethe lined area shown in FIG. 2 to show the location of the corneacontact 210 does not show breaks, the ring would be broken where each ofthe plurality of channels 212 occur, for example, and the cornea contact210 may not contact the cornea in the breaks. The cornea contact 210 maybe formed in or on the concave side of the enclosure 204 and formedunder a perimeter area of the insert 202. The cornea contact 210 mayprovide a buffer area for resting the ophthalmic device 200 on a user'seye, and may further improve the comfort of the ophthalmic device 200.In some embodiments, the insert 202 may affect the comfort of theophthalmic device 200, so the cornea contact 210 may be disposed underthe perimeter of the insert 202 to affect the comfort of the ophthalmicdevice 200. The cornea contact 210 may be raised relative to the concaveside of the ophthalmic device 200 inside the diameter of the corneacontact 210, e.g., the optic area 206. In some embodiments, the corneacontact 210 may not be raised outside of the perimeter of the insert202, and may instead blend into the skit 208. This raised area may notcontact the central cornea of the user's eye, which may provideclearance between the eye and the concave side of the optic area 206, atleast within the cornea contact 210 ring. The height of the clearancemay allow the ophthalmic device 200 to fit a wide variety of eye shapes,a majority of the eye population for example. This volume of spaceformed between the cornea and the ophthalmic device 200 may form a tearfluid chamber, for example, and may hold tear fluid.

The plurality of channels 212 may be formed in or on the enclosure 204and may extend through the cornea contact 210. Each of the channels 212may extend from a radius outside of the insert 202 radius to a radiusinternal of the insert 202 radius. For example, each of the channels 212may extend from just outside of the insert 202 to an inner edge of thecornea contact 210. In some embodiments, however, one or more channels212 of the plurality of channels 212 may extend through the skirt 208 toan edge of the enclosure 204.

The plurality of fenestrations 214 may extend through the enclosure 204and intersect with a proximate end of a respective one of the pluralityof channels 212. Each of the plurality of fenestrations 214 may extendfrom the convex side to the concave side of the ophthalmic device 200.On the concave side, the fenestrations 214 may couple to a respectiveone of the channels 212 so that an unobstructed path, e.g., a conduit,may be formed through the enclosure 204. The plurality of fenestrations214 may be formed outside of the insert 202.

The combination of the plurality of channels 212 and the plurality offenestrations 214 may form pathways/conduits between the tear fluidchamber and the eye external to the ophthalmic device 200. The pathwaysmay allow for the exchange of tear fluid between the tear fluid chamberand the eye external to the ophthalmic device 200 so to refresh the tearfluid in the tear fluid chamber to maintain ocular health while wearingthe ophthalmic device 200.

In some embodiments, the concave side of the enclosure 204 may have adifferent radius of curvature in the optic area 206 than in the skirtarea 208. Further, the concave side of the insert 202 may have a radiusof curvature that is different than the corresponding radius ofcurvature of the enclosure 204. The various radii of curvature, however,may desirably be formed so that the ophthalmic device 200 may fit amajority of the eye population. The clearance between the central corneaand the concave side of the ophthalmic device 200 due to the height ofthe cornea contact 210 may also affect the fit of the ophthalmic device200.

FIG. 3 is an illustrative cross-sectional view of a central area of anophthalmic device 300 including posterior and anterior features inaccordance with an embodiment of the present disclosure. The ophthalmicdevice 300 may be an example of the ophthalmic device 100. Theillustrated embodiment of the ophthalmic device 300 includes an insert302 and an enclosure 304. While the ophthalmic device 300 is not shownto include a skirt area, comparable to the skirt 108, the skirt area isomitted to focus on various features in the central area of theophthalmic device 300.

A posterior side of the insert 302 may have a radius of curvature R1. R1may desirably be selected, based on a statistical analysis of a largepopulation of eye shapes and sizes, to fit a majority of the eyepopulation. Further, a posterior side of the enclosure 304 may have aradius of curvature R2. As with the insert, R2 may desirably beselected, based on a statistical analysis of a large population of eyeshapes and sizes, to fit a majority of the eye population. In someembodiments, R1 and R2 may allow the ophthalmic device 300 to fitgreater than 95% of the eye population, for example. In someembodiments, R1 and R2 may be different. For example, R1 may be around8.5 mm whereas R2 may be around 8 mm.

The enclosure 304 may include an offset feature 316 and an alignmentfeature 318. The offset and alignment features 316 and 318,respectively, may be bumps formed in or on an anterior side of theenclosure 304. The offset features 316 may be formed inside of adiameter of the insert 302, and may assist in alignment of the insert302 and the enclosure 304 in a direction parallel to the optical axis ofthe ophthalmic device 300. Further, the offset features 316 may formclearance between an anterior side of the insert 302 and an internalsurface of the anterior side of the enclosure 304. In some embodiments,the clearance may be around 100 microns, but other clearance amounts arewithin the scope of the present disclosure.

The alignment features 318 may be bumps formed in the posterior side ofthe enclosure 304, and may be formed outside a diameter of the insert302. The alignment features 318 may provide alignment fiducials to aidassembly of the ophthalmic device 300. In some embodiments, thealignment features 318 may cause centration of the insert 302 within theenclosure 304.

The enclosure 304 may also include cornea contact 310. Cornea contact310 may be formed in/on the posterior side of the enclosure 304, and mayprovide a cornea contact area. The cornea contact area may aid incomfort of the ophthalmic device 300 while being worn by a user. In someembodiments, the cornea contact 310 may be shaped into a discontinuouscontoured profile, and arranged between a perimeter of the insert 302and the surface of the eye. The height 326 of the cornea contact, atleast with respect to a posterior side of the enclosure 304 within thecornea contact 310, may provide clearance of the posterior side of theenclosure 304 within the cornea contact 310 and the eye. This clearance,which may range from 50 to 200 microns, may further allow the ophthalmicdevice to be worn by a majority of the eye population. The corneacontact 310 may further has a radius of curvature that may be in therange of a natural radius of curvature of a user's eye surface, e.g., itmay mimic the cornea curvature in the area of contact, and may not be afeature on the posterior side of the enclosure 304 that excessivelydeforms the cornea, for example. Accordingly, the clearance created bythe cornea contact 310 and the radius of curvature of the cornea contact310 may add to the comfort of the ophthalmic device 300.

The clearance between the eye and the posterior side of the enclosure304 within the cornea contact 310 may further form a tear fluid chamber.The tear fluid chamber may be defined by the surface of the eye, theposterior side of the enclosure 304 and the cornea contact 310. The tearfluid chamber may provide a volume for tear fluid to accumulate, whichmay provide for ocular health. While not shown in the ophthalmic device300, channels and fenestrations, similar to the channels 112 andfenestrations 114, may be included in the enclosure 304. The channelsand fenestrations may provide a conduit for the exchange of tear fluidand oxygen between the tear fluid chamber and the eye external to theophthalmic device 300. The exchange of tear fluid may allow fresh tearfluid and oxygen to reach the central cornea area, while transportingmucus and debris away from the central cornea area.

While the cornea contact 310 is shown as a raised area of the enclosure304, in some embodiments only the side adjacent to the tear fluidchamber may be raised from the eye. In such an embodiment, the corneacontact 310 may blend into the enclosure 304 radially outward andcontinue to contact the eye in a direction toward the sclera.

FIG. 4 is an illustrative plan view of an ophthalmic device 400including posterior and anterior features in accordance with anembodiment of the present disclosure. The ophthalmic device 400, whichmay be similar to the ophthalmic device 100 in may aspects, may includevarious electronics to control a dynamic optic, for example. Theillustrated embodiment of the ophthalmic device 400 includes an insert402, an enclosure 404, control electronics 420 and 422, and an antenna424. The ophthalmic device 400 may be an on-eye wearable device or anintraocular device, and may provide accommodation to a user, forexample.

The insert 402 may be formed from soft or rigid biocompatible materials,and may be disposed within the enclosure 404. The insert 402 may atleast provide dynamic optical power to a user. For example, the insert402 may include a dynamic optic based on liquid crystal orelectrowetting techniques. The dynamic optic of the insert 402, whichmay be arranged in the optic area 406, may be controlled by the controlelectronics 420 and/or 422, which may be included in or on a layer ofthe insert 402. In some embodiments, the insert 402 may additionallyinclude static optical power. The insert 402 may further be formed froma plurality of optical elements arranged into a stack, which may includea substrate for the control electronics 420, 422, and the antenna 424.

The control electronics 420 and 422 may include various logic, circuits,power supplies, and batteries for controlling the dynamic optic and forcommunication with components external to the ophthalmic device 400. Theantenna 424, which may include multiple separate antennae in someembodiments, may be used to send and receive communication signalsand/or for wireless charging of related batteries and or power supplies.

The disclosed embodiment of the enclosure 404 includes a cornea contact410, channels 412, fenestrations 414, offset features 416, and alignmentfeatures 418. These various features and geometries, which may besimilar to like features and geometries of ophthalmic devices 100, 200and 300, may not be discussed in detail for sake of brevity. The offsetfeatures 416, which may be bumps formed in/on an anterior side of theenclosure 404, may form a clearance between the insert 402 and aninternal surface of the enclosure 404. Further, the offset features 416may provide alignment in a direction normal to the optic area 406. Thealignment features 418, which may be bumps formed in the anterior sideof the enclosure 404, may provide alignment fiducials to aid incentering the insert 402 within the enclosure 404.

The cornea contact 410 may be a discontinuous ring formed in or on aposterior side of the enclosure, and disposed under a perimeter of theinsert 402. The cornea contact 410 may provide vault to the optic area406, which may form a clearance over a user's central cornea area. Thisclearance may form a volume of space, such as the tear fluid chamberdiscussed above.

The channels and fenestrations 412 and 414, respectively, may be formedin the enclosure 404. For example, the channels 412 may be formed on theposterior side of the enclosure 404 and may extend through the corneacontact 410, which may form the discontinuous portions of the corneacontact 410. The channels 412 may extend from a radius outside of theinsert 402 to at least an inner radial edge of the cornea contact 410.Additionally, the channels 412 may intersect with, e.g., couple to,respective ones of the fenestrations 414 radially outside of the insert402. The channels and fenestrations 412 and 414, respectively, maycombine to form a conduit for the exchange of tear fluid between thetear fluid chamber and the eye external to the ophthalmic device 400. Insome embodiments, one or more of the channels 412 may extend to an outeredge of the enclosure 404, which may or may not intersect with afenestration 414.

The skirt 408 may provide a soft area outside of the insert 402 that maypromote ease of removal of the ophthalmic device 400. For example, theskirt 408 may be pinched by a user when removing the ophthalmic device400. Additionally, the channels and fenestrations 412 and 414,respectively, may assist with removal by preventing the occurrence ofsuction of the ophthalmic device 400 onto the user's eye.

FIG. 5 is a functional block diagram of an ophthalmic device 500including posterior and anterior features in accordance with anembodiment of the present disclosure. Ophthalmic device 500 may be anon-eye device, such as a contact lens or a smart contact lens, or animplantable device, such as an intraocular lens. In the depictedembodiment, ophthalmic device 500 includes an enclosure material 510formed to be either contact-mounted to a corneal surface of an eye orimplanted into an eye. The enclosure material 510 may be oneimplementation of the enclosure 104. A substrate 515 is embedded withinor surrounded by enclosure material 510 to provide a mounting surfacefor a power supply 520, a controller 525, an antenna 540, and variousinterconnects 545 and 550. The substrate 515 and the associatedelectronics may be one implementation of the control electronics 420and/or 422. Additionally, the substrate 515 may be included with theinsert 402, such as on a perimeter area of the insert 402. Theillustrated embodiment of power supply 520 includes an energy harvestingantenna 555, charging circuitry 560, and a battery 565. The illustratedembodiment of controller 525 includes control logic 570, accommodationlogic 575, and communication logic 580. As shown, accommodation actuator530 is disposed in the enclosure material 510.

Power supply 520 supplies operating voltages to the controller 525and/or the accommodation actuator 530. Antenna 540 is operated by thecontroller 525 to communicate information to and/or from ophthalmicdevice 500. In the illustrated embodiment, antenna 540, controller 525,and power supply 520 are disposed on/in substrate 515, whileaccommodation actuator 530 is disposed in enclosure material 510 (notin/on substrate 515). However, in other embodiments, the various piecesof circuitry and devices contained in ophthalmic device 500 may bedisposed in/on substrate 515 or in enclosure material 510, depending onthe specific design of ophthalmic device 500. For example, in oneembodiment, accommodation actuator 530 may be disposed on a transparentsubstrate.

Substrate 515 includes one or more surfaces suitable for mountingcontroller 525, power supply 520, and antenna 540. Substrate 515 can beemployed both as a mounting platform for chip-based circuitry (e.g., byflip-chip mounting) and/or as a platform for patterning conductivematerials (e.g., gold, platinum, palladium, titanium, copper, aluminum,silver, metals, other conductive materials, combinations of these, etc.)to create electrodes, interconnects, antennae, etc. In some embodiments,substantially transparent conductive materials (e.g., indium tin oxideor silver nanowire mesh) can be patterned on substrate 515 to formcircuitry, electrodes, etc. For example, antenna 540 can be formed bydepositing a pattern of gold or another conductive material on substrate515. Similarly, interconnects 545 and 550 can be formed by depositingsuitable patterns of conductive materials on substrate 515. Acombination of resists, masks, and deposition techniques can be employedto pattern materials on substrate 515. Substrate 515 can be a relativelyrigid material, such as polyethylene terephthalate (“PET”), parylene oranother material sufficient to structurally support the circuitry and/orelectronics within enclosure material 510. Ophthalmic device 500 canalternatively be arranged with a group of unconnected substrates ratherthan a single substrate 515. For example, controller 525 and powersupply 520 can be mounted to one substrate 515, while antenna 540 ismounted to another substrate 515 and the two can be electricallyconnected via interconnects. Substrate 515 may also be a continuouspiece of semiconductor, housing all or some of the aforementioned piecesof device architecture as integrated circuitry.

Substrate 515 can be shaped as a flattened ring with a radial widthdimension sufficient to provide a mounting platform for the embeddedelectronic components. Substrate 515 can have a thickness sufficientlysmall to allow substrate 515 to be embedded in enclosure material 510without adversely influencing the profile of ophthalmic device 500.Substrate 515 can have a thickness sufficiently large to providestructural stability suitable for supporting the electronics mountedthereon. For example, substrate 515 can be shaped as a ring with adiameter of about 10 millimeters, a radial width of about 1 millimeter(e.g., an outer radius 1 millimeter larger than an inner radius), and athickness of about 50 micrometers. Substrate 515 can optionally bealigned with the curvature of the eye-mounting surface of ophthalmicdevice 500 (e.g., convex surface). For example, substrate 515 can beshaped along the surface of an imaginary cone between two circularsegments that define an inner radius and an outer radius. In such anexample, the surface of substrate 515 along the surface of the imaginarycone defines an inclined surface that is approximately aligned with thecurvature of the eye mounting surface at that radius.

In the illustrated embodiment, power supply 520 includes a battery 565to power the various embedded electronics, including controller 525.Battery 565 may be inductively charged by charging circuitry 560 andenergy harvesting antenna 555. In one embodiment, antenna 540 and energyharvesting antenna 555 are independent antennae, which serve theirrespective functions of energy harvesting and communications. In anotherembodiment, energy harvesting antenna 555 and antenna 540 are the samephysical antenna that are time shared for their respective functions ofinductive charging and wireless communications with reader 505.Additionally or alternatively, power supply 520 may include a solar cell(“photovoltaic cell”) to capture energy from incoming ultraviolet,visible, and/or infrared radiation. Furthermore, an inertial powerscavenging system can be included to capture energy from ambientvibrations.

Charging circuitry 560 may include a rectifier/regulator to conditionthe captured energy for charging battery 565 or directly powercontroller 525 without battery 565. Charging circuitry 560 may alsoinclude one or more energy storage devices to mitigate high frequencyvariations in energy harvesting antenna 555. For example, one or moreenergy storage devices (e.g., a capacitor, an inductor, etc.) can beconnected to function as a low-pass filter.

Controller 525 contains logic to choreograph the operation of the otherembedded components. Control logic 570 controls the general operation ofophthalmic device 500, including providing a logical user interface,power control functionality, etc. Accommodation logic 575 includes logicfor receiving signals from sensors monitoring the orientation of theeye, determining the current gaze direction, focal distance of the userand/or relative position of the eyelid, and manipulating accommodationactuator 530 (focal distance of the contact lens) in response to thesephysical cues. The auto-accommodation can be implemented in real-timebased upon feedback from gaze tracking, or permit the user to selectspecific accommodation regimes (e.g., near-field accommodation forreading, far-field accommodation for regular activities, etc.).Communication logic 580 provides communication protocols for wirelesscommunication with reader 505 via antenna 540. In one embodiment,communication logic 580 provides backscatter communication via antenna540 when in the presence of an electromagnetic field 571 output fromreader 505. In one embodiment, communication logic 580 operates as asmart wireless radio-frequency identification (“RFID”) tag thatmodulates the impedance of antenna 540 for backscatter wirelesscommunications. The various logic modules of controller 525 may beimplemented in software/firmware executed on a general purposemicroprocessor, in hardware (e.g., application specific integratedcircuit), or a combination of both.

Ophthalmic device 500 may include various other embedded electronics andlogic modules. For example, a light source or pixel array may beincluded to provide visible feedback to the user. An accelerometer orgyroscope may be included to provide positional, rotational, directionalor acceleration feedback information to controller 525.

The illustrated embodiment also includes reader 505 with a processor582, an antenna 584, and memory 586. Memory 586 in reader 505 includesdata storage 588 and program instructions 590. As shown reader 505 maybe disposed outside of ophthalmic device 500, but may be placed in itsproximity to charge ophthalmic device 500, send instructions toophthalmic device 500, and/or extract data from ophthalmic device 500.In one embodiment, reader 505 may resemble a conventional contact lensholder that the user places ophthalmic device 500 in at night to charge,extract data, clean the lens, etc.

External reader 505 includes an antenna 584 (or group of more than oneantennae) to send and receive wireless signals 571 to and fromophthalmic device 500. External reader 505 also includes a computingsystem with a processor 582 in communication with a memory 586. Memory586 is a non-transitory computer-readable medium that can include,without limitation, magnetic disks, optical disks, organic memory,and/or any other volatile (e.g., RAM) or non-volatile (e.g., ROM)storage system readable by the processor 182. Memory 586 can include adata storage 588 to store indications of data, such as data logs (e.g.,user logs), program settings (e.g., to adjust behavior of ophthalmicdevice 500 and/or external reader 505), etc. Memory 586 can also includeprogram instructions 590 for execution by processor 582 to cause theexternal reader 505 to perform processes specified by the instructions590. For example, program instructions 590 can cause external reader 505to provide a user interface that allows for retrieving informationcommunicated from ophthalmic device 500 or allows transmittinginformation to ophthalmic device 500 to program or otherwise selectoperational modes of ophthalmic device 500. External reader 105 can alsoinclude one or more hardware components for operating antenna 584 tosend and receive wireless signals 571 to and from ophthalmic device 500.

External reader 505 can be a smart phone, digital assistant, or otherportable computing device with wireless connectivity sufficient toprovide the wireless communication link 571. External reader 505 canalso be implemented as an antenna module that can be plugged into aportable computing device, such as in an embodiment where thecommunication link 571 operates at carrier frequencies not commonlyemployed in portable computing devices. In some instances, externalreader 505 is a special-purpose device configured to be worn relativelynear a wearer's eye to allow the wireless communication link 571 tooperate with a low power budget. For example, the external reader 505can be integrated in a piece of jewelry such as a necklace, earring,etc. or integrated in an article of clothing worn near the head, such asa hat, headband, etc.

The above description of illustrated embodiments of the invention,including what is described in the Abstract, is not intended to beexhaustive or to limit the invention to the precise forms disclosed.While specific embodiments of, and examples for, the invention aredescribed herein for illustrative purposes, various modifications arepossible within the scope of the invention, as those skilled in therelevant art will recognize.

These modifications can be made to the invention in light of the abovedetailed description. The terms used in the following claims should notbe construed to limit the invention to the specific embodimentsdisclosed in the specification. Rather, the scope of the invention is tobe determined entirely by the following claims, which are to beconstrued in accordance with established doctrines of claiminterpretation.

What is claimed is:
 1. An ophthalmic device, comprising: an enclosurehaving an insert disposed therein, the enclosure including: a corneacontact disposed on a posterior side of the enclosure and arranged torest on a user's cornea outside of a central cornea area when theophthalmic device is worn by a user; and a channel formed in theposterior side of the enclosure, wherein the channel extends through thecornea contact from at least radially outside of the insert to an inneredge of the cornea contact; and a plurality of offset features formed inthe enclosure and radially inside of the insert, each of the pluralityof offset features configured to provide clearance between the insertand a surface of the enclosure.
 2. The ophthalmic device of claim 1,further comprising: a plurality of alignment features formed in theenclosure and disposed radially outside of the insert, the plurality ofalignment features configured to provide alignment markers for aligningan optical axis of the insert with a central axis of the enclosure. 3.The ophthalmic device of claim 2, wherein the plurality of offsetfeatures and the plurality of alignment features are formed in ananterior side of the ophthalmic device or a posterior side of theophthalmic device.
 4. The ophthalmic device of claim 1, furthercomprising: a fenestration formed through the enclosure, wherein thefenestration is disposed radially outside of the insert and positionedto intersect with the channel radially outside of the insert andradially outside of the cornea contact.
 5. The ophthalmic device ofclaim 4, wherein the enclosure includes a plurality of channels and aplurality of fenestrations, and wherein each of the plurality offenestrations intersect with an end of a respective one of the pluralityof channels.
 6. The ophthalmic device of claim 5, wherein at least oneof the plurality of channels extend all the way to a perimeter edge ofthe enclosure.
 7. The ophthalmic device of claim 5, wherein theplurality of fenestrations and the plurality of channels provide aconduit for tear fluid exchange between a tear fluid chamber and the eyeexternal to the ophthalmic device.
 8. The ophthalmic device of claim 7,wherein the tear fluid chamber is a volume of space between a user's eyeand a posterior side of the enclosure and encircled by the corneacontact.
 9. The ophthalmic device of claim 1, wherein the cornea contactcomprises a toroidal-shaped ring that raises from the posterior side ofthe enclosure.
 10. The ophthalmic device of claim 9, wherein thetoroidal-shaped ring has at least one discontinuous section throughwhich the channel extends and wherein the toroidal-shaped ring extendsat least partially under the insert.
 11. The ophthalmic device of claim1, wherein the insert is a rigid, gas permeable polymeric insert thatprovides optical power and the enclosure is formed from a hydrogel or asilicone hydrogel.
 12. An ophthalmic device, comprising: a rigid insert;and an enclosure enveloping the rigid insert, wherein the enclosureincludes: a cornea contact formed on a concave side of the enclosure,the cornea contact having a toroidal-shape that protrudes from theconcave side of the enclosure and is disposed under at least a portionof the rigid insert, wherein the toroidal-shape of the cornea contactincludes a plurality of discontinuous sections; and a plurality ofchannels formed on the concave side of the enclosure and each extendingthrough a corresponding one of the discontinuous sections of the corneacontact.
 13. The ophthalmic device of claim 12, further comprising: aplurality of offset features formed in the enclosure and inside adiameter of the rigid insert, each of the plurality of offset featuresconfigured to provide clearance between an anterior side of the rigidinsert and a surface of the enclosure.
 14. The ophthalmic device ofclaim 12, further comprising: a plurality of alignment features formedin the enclosure and outside a diameter of the rigid insert, theplurality of alignment features configured to provide alignment markersfor aligning an optical axis of the rigid insert with a central axis ofthe enclosure.
 15. The ophthalmic device of claim 14, wherein each ofthe plurality of alignment features is formed in an anterior side of theenclosure.
 16. The ophthalmic device of claim 12, wherein a radius ofcurvature of a concave side of the rigid insert is different than aradius of curvature of the concave side of the enclosure.
 17. Theophthalmic device of claim 12, further comprising: a plurality offenestrations formed through the enclosure and radially outside of therigid insert, each of the plurality of fenestrations intersecting with arespective one of the plurality of channels.
 18. The ophthalmic deviceof claim 17, wherein the cornea contact raises an optic area of theophthalmic device so that there is clearance between a surface of auser's cornea and the concave side of the enclosure within the corneacontact, and wherein a space between the user's cornea and the concaveside of the enclosure within the cornea contact forms a tear fluidchamber, and wherein the plurality of channels and the plurality offenestrations allow exchange of tear fluid between the tear fluidchamber and the user's eye.
 19. The ophthalmic device of claim 12,wherein at least one of the plurality of channels extends to a perimeteredge of the enclosure.
 20. An ophthalmic device, comprising: anenclosure having an insert disposed therein, the enclosure including: acornea contact disposed on a posterior side of the enclosure andarranged to rest on a user's cornea outside of a central cornea areawhen the ophthalmic device is worn by a user; and a channel formed inthe posterior side of the enclosure, wherein the channel extends throughthe cornea contact from at least radially outside of the insert to aninner edge of the cornea contact; and a plurality of alignment featuresformed in the enclosure and disposed radially outside of the insert, theplurality of alignment features configured to provide alignment markersfor aligning an optical axis of the insert with a central axis of theenclosure.